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    Summary
    EudraCT Number:2019-003779-20
    Sponsor's Protocol Code Number:SCO101-001
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-10-02
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedDenmark - DHMA
    A.2EudraCT number2019-003779-20
    A.3Full title of the trial
    An open-label phase II prospective clinical trial to investigate safety, tolerability, maximum tolerated dose and anti-tumor effect for SCO-101 in combination with FOLFIRI as a safe and efficient treatment modality in metastatic or advanced colorectal cancer (mCRC) patients with acquired FOLFIRI resistant cancer disease.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    En åben fase II undersøgelse af sikkerhed, tolerabilitet, højeste tolerable dosis og anti-tumor effekt af SCO-101 i kombination med FOLFIRI som en sikker og effektiv behandling af patienter med udbredt kolorektalkræft, der har udviklet behandlingsresistens overfor behandling med FOLFIRI
    A.4.1Sponsor's protocol code numberSCO101-001
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorScandion Oncology A/S
    B.1.3.4CountryDenmark
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportScandion Oncology A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationScandion Oncology A/S
    B.5.2Functional name of contact pointClinical Trials Infomation
    B.5.3 Address:
    B.5.3.1Street AddressFruebjergvej 3
    B.5.3.2Town/ cityCopenhagen
    B.5.3.3Post code2100
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4524943782
    B.5.6E-mailpmv@scandiononcology.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameSCO-101
    D.3.2Product code SCO-101
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSCO-101
    D.3.9.1CAS number 265646-85-3
    D.3.9.2Current sponsor codeSCO-101
    D.3.9.3Other descriptive nameN-[4-bromo-2-(1H-1,2,3,4-tetrazol-5-yl)phenyl]-N'-[3,5- bis(trifluoromethyl)phenyl]urea
    D.3.9.4EV Substance CodeSUB213749
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number50 to 150
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Metastatic or advanced colorectal cancer (mCRC) with acquired resistance to chemotherapy 
    E.1.1.1Medical condition in easily understood language
    Cancer in the colon or rectal area, which has spread to other parts of the body and which is no longer sensitive to chemotherapy
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10052362
    E.1.2Term Metastatic colorectal cancer
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. To determine the safety and toxicity profile of SCO-101 in combination with FOLFIRI
    2. Stage 1: Maximum tolerated dose (MTD) of SCO-101 in combination with FOLFIRI as evaluated by CTCAE v. 5.0
    3. Stage 2 and 3: To assess the Objective Response Rate (ORR) according to RECIST 1.1 criteria after 8 chemotherapy cycles.
    E.2.2Secondary objectives of the trial
    1. To assess the Clinical Benefit Rate (CBR), Progression Free Survival (PFS), overall survival (OS), and Objective Response Rate (ORR)
    2. To assess the Duration of Response (DOR) in patients with an objective response, and DOR compared to DOR of initial FOLFIRI treatment (without SCO-101)
    3. To establish the PK profile of SCO-101 in combination with FOLFIRI and Irinotecan and SN-38 during stage 1 of the clinical study
    4. To evaluate clinical biomarkers to predict response to SCO-101 treatment in combination with FOLFIRI. The following biomarkers will be evaluated:
    o In all stages:
    Total, unconjugated and conjugated bilirubin,
    UGT1A1 polymorphism
    o Only in stages 2 and 3:
    ABCB1/ABCG2/SRPK1/UGT1A1 immunohistochemistry
    5. To evaluate RAS mutation status by means of Circulating cell free tumor DNA (ctDNA) in patients enrolled in stage 2 and stage 3
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Ability to understand and willingness to provide written informed consent before any trial-related activities.
    2. Age 18 years or older.  
    3. Histologically verified colorectal adenocarcinoma;
    4. Non resectable mCRC in patients:
    A. Stage 1 only: with or without BRAF, KRAS or repair enzyme mutations.
    B. Stage 2 and stage 3 only: without known BRAF, KRAS or repair enzyme mutations
    5. A. Stage 1 only: Documented progressive disease on FOLFIRI treatment regimen (with or without antiangiogenetic and EGFR inhibitory biological treatment)
    5. B. Stage 2 and stage 3 only: Documented progressive disease with a prior benefit (SD for more than 16 weeks, or CR or PR) on FOLFIRI treatment regimen (with or without antiangiogenetic and EGFR inhibitory biological treatment)
    6. Maximum reduction of 33% in prior dose of FOLFIRI
    7. No indication for treatment with an oxaliplatin-containing treatment regimen. The patient may have received oxaliplatin treatment after treatment with FOLFIRI.
    8. A. Stage 1 only: Evaluable disease by CT scan or MRI
    B. Stage 2 and stage 3 only: Measurable disease by CT scan or MRI, according to RECIST 1.1.  
    9. Performance status of ECOG ≤ 1.  
    10. Recovered to Grade 1 or less from prior surgery or acute toxicities of prior radiotherapy or treatment with cytotoxic or biologic agents.  
    11. ≥ 2 weeks must have elapsed since any prior surgery 
    12. Adequate conditions as evidenced by the following clinical laboratory values:   
    •Absolute neutrophils count (ANC) ≥ 1.5 x 10^9/L  
    • Haemoglobin is at least 6,0 mmol/L  
    • Platelets ≥ 100 x 10^9 /L  
    • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN 
    • Total serum bilirubin ≤ 1.0 ULN  
    • Alkaline phosphatase ≤ 2.5 x ULN  
    • Creatinine ≤ 1.5 ULN  
    • Creatinine clearance within normal limits. 
    • Adequate blood clothing function as defined by the International Normalized Ratio (INR) ≤ 1.2;
    13. Life expectancy equal to or longer than 3 months.   
    14. Sexually active males and females of child-producing potential must use adequate highly effective contraception during the trial and for at least 6 months after the last dose of study drug. Moreover, monthly pregnancy testing will be done during the treatment phase of the trial. (Highly effective contraceptive measures are methods that can achieve a failure rate of less than 1% per year. These include: intrauterine devices, hormonal contraceptives associated with inhibition of ovulation (oral, implants, transdermal patches, hormonal vaginal devices or injections with prolonged release). A vasectomised partner or sexual abstinence may be regarded as highly effective methods, if this is the usual and preferred lifestyle of the subject. Sterilised or infertile subjects are exempt from the requirement to use contraception. In order to be considered sterile or infertile, subjects must generally have undergone surgical sterilisation (vasectomy/bilateral salpingectomy, hysterectomy and bilateral oophorectomy) or be postmenopausal defined as 12 months or more with no menses prior to enrolment. Double-barrier methods (condom+cervical cap with spermicide) are not considered highly effective)
    15. Signed informed consent.
    E.4Principal exclusion criteria
    1. Concurrent chemotherapy, radiotherapy, or other investigational drug except non-disease related conditions (e.g. insulin for diabetes) during study period.  
    2. Malabsorption syndrome or previous surgeries with resection of the stomach or small intestine, whereby absorption of SCO-101 may be affected.   This includes patients with ileostomy.
    3. Difficulty in swallowing tablets. 
    4. Clinical symptoms of CNS metastases requiring steroids.
    5. Any active infection requiring parenteral or oral antibiotic treatment.  
    6. Known HIV positivity.  
    7. Known active hepatitis B or C. 
    8. Clinical significant (i.e. active) cardiovascular disease:
    • Stroke within ≤ 6 months prior to day 1  
    • Transient ischemic attach (TIA) within ≤ 6 months prior to day 1  
    • Myocardial infarction within ≤ 6 months prior to day 1  
    • Unstable angina  
    • New York Heart Association (NYHA) Grade II or greater congestive heart failure (CHF)  
    • Serious cardiac arrhythmia requiring medication 
    9. Mental status is not fit for clinical study or CNS disease including symptomatic epilepsy.   
    10. Other medications or conditions that in the Investigator’s opinion would contraindicate study participation of safety reasons or interfere with the interpretation of study results.   Other severe medical conditions, including serious heart disease, unstable diabetes, uncontrolled hypercalcaemia, clinically active infections or previous organ transplants. Participation in another clinical trial with experimental medication within 30 days prior to registration.
    11. Known hypersensitivity to irinotecan, 5FU or capecitabine
    12. Pregnant Wwomen or women who are breastfeeding. 
    E.5 End points
    E.5.1Primary end point(s)
    1. Safety and tolerability by assessing the number, frequency, and severity of adverse events (AEs) collected from the time of first treatment until four weeks after end of treatment to evaluate safety of SCO-101 in combination with FOLFIRI determined according to CTCAE version 5.0
    2. Stage 1: Maximum tolerated dose (MTD) by evaluation of dose-limiting toxicities (DLTs) of SCO-101 in combination with FOLFIRI
    3. Stages 2 and 3: Objective response rate (ORR) defined as CR and PR using the RECIST v. 1.1 after 8 chemotherapy cycles.
    E.5.1.1Timepoint(s) of evaluation of this end point
    According to the protocol
    E.5.2Secondary end point(s)
    1. Progression free survival (PFS) defined as time in months from the date of first study treatment to the date of disease progression or death from any cause, whichever comes first;
    2. Duration of response (DOR) (from first response to progression);
    3. Duration of response (DOR) after administration of SCO-101 compared to DOR from patients' initial FOLFIRI treatment regimen (i.e. without SCO-101).
    4. Overall survival (OS) defined as time in months from the date of first study treatment to the date of death;
    5. ORR defined as CR and PR using the RECIST v. 1.1 for the entire treatment period
    6. Clinical benefit rate (CBR) defined as the number of patients obtaining CR, PR, or SD > 16 weeks according to RECIST v.1.1.
    7. Pharmacokinetic profiles of SCO-101, Irinotecan, and SN-38 will be determined in patients enrolled during Stage 1 of the clinical study, by means of: Time to maximum drug plasma concentration (tmax), Half-life (T½), Volume of Distribution (Vd/F), Clearance (CL/F), Area Under the plasma drug Concentration-time curve (AUC) and Maximum drug plasma concentration (Cmax).
    8. Biomarker evaluation:
    o Changes in levels of total, unconjugated and conjugated bilirubin in blood, from baseline (i.e., prior first dose of SCO-101), at each cycle, and until end of treatment; and correlation between
    In stage 1, levels of bilirubin in blood and PK parameters for SCO-101 and SN-38 during cycle 1 of treatment, and
    In stages 2 and 3, levels of bilirubin in blood and the safety and tolerability of SCO-101.
    o Selected UGT1A1 polymorphism (from a pre-treatment blood sample).
    o Only in stages 2 and 3: Efficacy of molecular biomarkers ABCB1/ABCG2/SRPK1/UGT1A1 determined by immunohistochemistry to predict clinical response to SCO-101 treatment (in archival and fresh pretreatment tumor biopsy);
    9. Evaluation of ctDNA RAS-mutation status from a pre -and a post treatment blood sample in patients enrolled in stage 2 and stage 3.
    E.5.2.1Timepoint(s) of evaluation of this end point
    According to the protocol
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 22
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state47
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    In the follow-up period, if the individual patient is found to benefit from study treatment, they will be offered the possibility to continue treatment with SCO 101 in combination with FOLFIRI outside the present protocol and at the discretion of the investigator. Continued treatment with SCO 101 after end of the treatment period in this study will be agreed between the Sponsor and the investigator.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-11-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-01-28
    P. End of Trial
    P.End of Trial StatusOngoing
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